![](https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjS1u-YRorRoMWqNPLhtLlVBCd34cD7nCoLGPQ7PtEmMw3H6Ba8smisNVNwlklS5XGWa7YoMGGCK8N5bRdbUm__EBVxQFXwZxIrNnuClb9ds4r_a6TO6C2Of-8nKYJALEk-TJpOBYdNJgA/s320/roche.jpg)
Today Roche and Polyphor announced a deal
for Polyphor’s anti-pseudomonas drug POL7080. Polyphor has been one of my clients for a
number of years and I am extremely happy for them and for the world that this
deal has gone through. Although the
upfront payment was just under $40 million, the deal terms could be as much as
$500 million given that all the milestones are attained. The drug has completed basic phase I studies
and is ready for phase II development. The development of an antibiotic that targets only a single
pathogen, even one like Pseudomonas
aeruginosa – one of the most feared killers of hospitalized patients – will
be challenging to the highest degree. The other challenge is the commercial
one. What price will Roche be able to attain for such an antibiotic assuming
that they can demonstrate that it is active in patients with highly resistant
Pseudomonas infections (see my blog
on this)? Therefore, this is a high-risk deal.
Given the risk, I see the deal terms as being more than reasonable.
The question remaining in my mind is the following. Can Roche do this? Are they up to this very
difficult regulatory, clinical, developmental and commercial challenge? My experience with companies like Roche,
where they have exited from the anti-infectives area years ago (for Roche that
would be 1999), everyone internally with the appropriate expertise to meet such
a challenge is long gone. These companies struggle for years to rebuild – and even
then there is the issue of corporate patience while the rebuilding struggles go
on. Will the corporation remain resolved to go through with their commitments
as they begin to understand the enormity of the difficulties ahead?
In this case – I am rooting for Roche! I know how difficult
this decision must have been for them. I also think that the regulatory
authorities must get some kudos (especially EMA but also FDA with its recent unmet
needs guidance). Without a
regulatory path forward, products like POL7080 could never see the light of
day. Next – we need to get to value based pricing. Without this – the commercial prospects for
POL7080 are nil and a failure based on a commercial bomb will kill antibiotic
discovery and development for even more decades to come.
But – all that said – Go Roche!
No comments:
Post a Comment